Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Novacea.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Novacea
ClinicalTrials.gov Identifier:
NCT00285675
First received: January 31, 2006
Last updated: May 30, 2006
Last verified: January 2006
  Purpose

The purpose of this study is to monitor the safety of continued DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 (ASCENT) or DN101-004 (NSCLC) Studies.


Condition Intervention Phase
Androgen Independent Prostate Cancer (AIPC)
Non Small Cell Lung Cancer (NSCLC)
Drug: DN-101 (calcitriol) - Drug
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004

Resource links provided by NLM:


Further study details as provided by Novacea:

Estimated Enrollment: 25
Study Start Date: April 2006
Estimated Study Completion Date: January 2008
Detailed Description:

This is a multicenter, open-label trial of DN-101 and docetaxel combination therapy to monitor the safety of ongoing DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 or DN101-004 studies. For subjects enrolled in DN101-002 study, only subjects randomized to the DN-101 treatment arm and are currently receiving study drug (including subjects on study suspension / holiday) will be included in the current study. For subjects enrolled in DN101-004 study, only subjects who are receiving study treatment will be included.

Safety will be assessed throughout the study. Safety evaluations will consist of a modified physical exam (vital signs and weight) and laboratory assessments. Modified physical exam should be performed at the beginning of each treatment cycle. Docetaxel-related laboratory assessments will be performed per standard of care as noted in the labeling. DN-101-related laboratory assessments for serum calcium and serum creatinine will be performed at the beginning of each treatment cycle. Clinically significant abnormal laboratory values will be reported as adverse events.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior participation in DN101-002 or DN101-004 studies, where the subject received at least one dose of DN-101
  • Able and willing to give written informed consent

Exclusion Criteria:

  • Disease progression or unacceptable toxicity while previously enrolled in DN101-002 or DN101-004 studies
  • Prior investigational therapy other than DN-101 within 30 days of enrollment
  • Known hypersensitivity to calcitriol
  • Pregnancy (women of childbearing potential only)
  • Greater than 90 days has elapsed from termination of DN101-002 or DN101-004 studies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285675

Locations
United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
Pacific Hematology Oncology Associates
San Francisco, California, United States, 94115
Kaiser Permanente Medical Group, Northern California
Vallejo, California, United States, 94589
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
United States, North Carolina
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
NW Kaiser Permanente Portland
Portland, Oregon, United States, 97227
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Alta Bates Comprehensive Center
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
University of Pittsburgh,William Copper Ambulatory Care, Pavillion Hellman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232-1305
United States, Texas
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Washington
Northwest Cancer Specialists Vancouver Office
Vancouver, Washington, United States, 98684
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute, Department of Medicine
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Novacea
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00285675     History of Changes
Other Study ID Numbers: 011-016
Study First Received: January 31, 2006
Last Updated: May 30, 2006
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Novacea:
Calcitriol, DN-101, Androgen Independent Prostate Cancer (AIPC), Prostate Cancer, Non Small Cell Lung Cancer (NSCLC)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Prostatic Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Calcitriol
Docetaxel
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 23, 2014